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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP, acceptable, well-documented publication of a multicentre study with 11454 allergic contact dermatitis patients, which meets basic scientific principles. Patch test data and data from patients's history were collected from the 24 departments participating in the Information Network of Departments of dermatology from 1 january 1990 to 31 december 1994.

Data source

Reference
Reference Type:
publication
Title:
Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study
Author:
Schnuch A et al.
Year:
1998
Bibliographic source:
British Journal of Dermatology 138, 467-476

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Patch-tests were performed according to recommendations of the International Contact Dermatitis Research Group and the German contact Dermatitis Group.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
human patch test: multicentre study with 11454 allergic contact dermatitis patients, which meets basic scientific principles

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 2 % in petrolatum

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Challengeopen allclose all
Route:
other: patch-tests with allergic contact dermatitis patients, see text field results
Vehicle:
petrolatum
Concentration / amount:
2%
No. of animals per dose:
11454 patients
Details on study design:
see text field results

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
2 %
No. with + reactions:
11
Total no. in group:
11 454
Clinical observations:
positive reaction
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2 %. No with. + reactions: 11.0. Total no. in groups: 11454.0. Clinical observations: positive reaction.
Reading:
1st reading
Group:
test group
Dose level:
2 %
No. with + reactions:
51
Total no. in group:
11 454
Clinical observations:
questionable/irritative response
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2 %. No with. + reactions: 51.0. Total no. in groups: 11454.0. Clinical observations: questionable/irritative response.
Group:
negative control
Remarks on result:
not measured/tested
Remarks:
Human patch test
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
Human patch test

Any other information on results incl. tables

Patch testing:

Nine of 24 centres applied patch tests for 24 h, the remainder (15 of 24) for 48 h. Readings were done until at least 72 h after application of the test chambers. For this study only readings at 72 h were considered.

11/11454 patients showed a positive reaction with BHT;
51/11454 showed a questionable/irritative response.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In the patch test 11/11454 patients showed a positive reaction with BHT and 51/11454 patients showed a questionable/irritative response. BHT was assessed as negative in the patch test with 11454 patients (Schnuch, 1998).